FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • How To Prevent (Or Resolve) Communication Issues With Your CMO’s Project Manager
    How To Prevent (Or Resolve) Communication Issues With Your CMO’s Project Manager

    You are on your weekly project conference call with your CMO, discussing a product-filling project which is on track. The CMO’s project manager says, “Oh, I am going to go off agenda and ask for your signature by today to go forward with a machine-testing plan. If we don’t do it tomorrow, we might need to push your production run by a couple of weeks.” This is the first you have heard of it, so you are reacting on several levels.

  • Is It Time For A Standardized CMC Knowledge Base?
    Is It Time For A Standardized CMC Knowledge Base?

    At small pharma companies, most of the CMC (chemistry, manufacturing, and controls) knowledge base is generated by a global array of outside providers.  The companies are challenged to create and manage a high-functioning knowledge base of information with little or no support staff. Let’s start with some examples of the current state.

  • Using Trending As A Tool For Risk-Based Thinking
    Using Trending As A Tool For Risk-Based Thinking

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.

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PHARMA OUTSOURCING WHITE PAPERS

Insights And Tips When Addressing Bioburden Challenges Insights And Tips When Addressing Bioburden Challenges

This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing

White paper on the risks related to bioburden downstream processing and the solutions available to mitigate these risks. Topics covered include improvements in raw material quality, equipment design, chromatography resin properties, and ways of working.

3 Decisions That Impact Shipping High-Value Active Packaging Containers

It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of blockbuster drug from South East Asia destined for Russia. In France, the roads are closed for days due to a monster snowstorm, with your irreplaceable shipment of investigational drugs stopped somewhere en route between Paris and the clinical trial site. Will all be lost, or can informed choices made before the shipment departs ensure product safety despite unforeseen circumstances?

Application Note: CFS 1200™ Sealing Process
Capsugel's CFS 1200™ Liquid & Filling machine utilizes their patented LEMS® technology to create a robust and impervious seal without the need for banding. This application note describes this sealing process. Submitted by Capsugel
On Target With Antibody Drug Conjugates

Few would dispute the fact that pharmaceutical formulation has become increasingly challenging. The difficulties all start with the ingredients used to make finished drugs. As more Active Pharmaceutical Ingredient (API) and excipient manufacturing moves offshore, particularly to India and China, there have been increasing complaints of variable quality and tightening supply. Ingredients have never officially been covered by existing pharmaceutical good manufacturing practices (GMPs), although different countries follow guidelines set by WHO, as well as ICH Q7. By Vijay Shah, Executive Director & Chief Operating Officer of Piramal Enterprises

Hypromellose Capsule For Optimum Formulation Of Pharma Dosage Forms

Hypromellose capsules were originally formulated with a secondary gelling agent. This article discusses the rationale for developing Capsugel’s Vcaps Plus capsules without a gelling agent.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Comparing Recombinant Protein Production With A Shake Flask And A Bioreactor

This application note compares cell growth and recombinant protein production of multiple Chinese hamster ovary (CHO) cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplements.

Improved Bioprocessing Measurement And Control

In this application note, three standard field service procedures for TruDO sensors are described: replacement of the membrane, refilling of the electrolyte solution, and cleaning/replacement of the cathode. 

Chromatographic Processes: Minimize Risks With Poorly Packed Columns

Good column packing is essential for any chromatographic process and plays a key role in the large-scale commercial manufacture of biopharmaceuticals. A bed packed too densely may crack, which can lead to channeling and early breakthrough. A bed packed too loosely can further compress, causing a liquid gap where mixing can occur. Either instance will lead to costly process disruptions and loss of valuable product. Proper packing eliminates such concerns and ensures a stable bed that performs according to expectations over many processing cycles.

How Pacira Pharma Is Working To Help Curb The Opioid Epidemic

The most effective way to stop opioid dependence is to eliminate the use of these addictive drugs after surgery altogether. This was the goal of Pacira Pharmaceuticals.

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

  • Could A Fear Of QbD Slow Your Breakthrough Therapy Drug’s Speed To Market?
    Could A Fear Of QbD Slow Your Breakthrough Therapy Drug’s Speed To Market?

    As pharma continues to evolve, the drive to pursue new cutting-edge drugs will become even greater. For those companies competing to push the boundaries of innovation, a fear of implementing QbD might end up being the biggest threat in its race to the finish.

  • Bioburden Sources You Might Have Missed
    Bioburden Sources You Might Have Missed

    A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.

  • Anticipating The Formulation Challenges Of Complex Molecules
    Anticipating The Formulation Challenges Of Complex Molecules

    Due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.

  • Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off
    Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off

    With biologics filling the pipelines of life sciences companies more than ever, the biopharmaceutical industry needs to rethink its view of quality. Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.

  • Cost And Impact Of A Bioburden Incident
    Cost And Impact Of A Bioburden Incident

    Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks.

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OUTSOURCING EVENTS

Preparing eCTD Submissions: A Step-By-Step Guide September 19, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Improving Product Quality During Technical Transfer – Minimizing Risk, Maximizing Results September 20, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
1st International Validation Week September 26 - 29, 2017
İSTANBUL
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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